IntePros is looking for a Design Quality Documentation Control Specialist to join one of our growing Medical Device Clients in Scottsdale, AZ. The Design Quality Documentation Control Specialist will provide document control services to support a multi-functional team environment. This role will support document control and database administration activities within the Quality team and will identify areas of improvement. This role will handle projects and tasks consistent with internal procedures and acceptance criteria, while meeting company and regulatory requirements.
Design Quality Documentation Control Specialist Responsibilities :
- Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
- Manage and maintain traceable, accountable, password protected, documentation system in compliance with Corporate and site Quality requirements
- Ensure compliance with periodic review requirements for all procedures.
- Ensure consistency of document structure & compliance to company procedures, ISO standards, GDPs & cGMPs.
- Work cross-functionally with individuals and projects teams to ensure successful documentation release.
- Provide quality document control oversight on documentation and reports.
- Review documents for clarity, grammar.
Design Quality Documentation Control Specialist Additional Responsibilities :
Education
Associate's Degree in technical or business-related field required andBachelor's Degree preferredDesign Quality Documentation Control Specialist Work Experience :
Minimum 3 years of experience in regulated Quality Assurance / Quality Control required andRelevant work history and / or experience may be considered in lieu of degree required andExperience with managing Document Control activities within a regulated industry required andExperience with quality systems such as ISO 9001, ISO 13485, 21 CFR 820 preferred andExperience with MasterControl (preferred) or electronic document management systemsDesign Quality Documentation Control Specialist Preferred Skills :
Ability to work independently, multi-task and thrive in fast-paced environmentExcellent written and verbal communication skillsMust have effective problem solving and interpersonal skillsProficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power PointAbility to accurately collect and organize dataAble to be aware of all relevant SOPs as per Company policy and Quality ManualAble to comply with the company's safety policy at all times#LI-DR2